Job Description
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Lead implementation of the site internal audit program.
- Lead the implementation of the site inspection readiness program to ensure site permanent inspection readiness.
- Responsible for ensuring that the process for the manufacture of Biologics is in compliance with cGMP and the associated regulatory requirements.
- Responsible for ensuring that there is an effective Quality Management System is in place.
- Be an advocate of continuous improvement in the Quality Management Systems.
- Drive compliance direction by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
- Lead proactive evaluation of site compliance against emerging regulatory trends.
- Ensure that quality issues are identified, addressed and resolved.
- Maintain Quality related metrics related to the Site Internal Audit program, ensuring effective communication and follow up of same.
- Represent the Quality Management System as appropriate during GMP inspections.
- Lead and perform internal audits (facility, system and walkthrough) in addition to management of the internal audit schedule at the site.
- Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals.
- Perform audits at regional sites, and host regional guest auditors (as applicable). Lead by example and apply cutting edge, risk-based audit techniques.
- Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
- Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
- Generate and report metrics / trends for program adherence to requirements and effectiveness.
- The motivation to be an inspiring member of a high performing team.
- Communication, decision making, people influencing and project management skills.
- Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues.
- Ambition and drive to develop and advance their career within the company and have a passion for continuous development and education.
- Seasoned leader with the expertise and leadership (team leader expertise) attributes that will ensure success in this highly responsible role.
- Expert level of knowledge of cGMP and Quality System regulations as they pertain to the site.
- 10% travel required.
What skills you will need:
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
- 12 years experience in the Pharmaceutical or Biological industry.
- 4 years experience in delivering Site Internal Audit programs and Inspection Readiness programs in a regulated environment.
- GMP Audit experience in the Pharmaceutical industry.
- Proven record of accomplishments of working in a Pharma/Biopharma company or related industry is desirable.
- Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
- Experience working in a GMP/regulated environment is desirable.
- Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
So, if you are ready to:
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.